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OpenTrials
Completed

NCT Number: NCT00942240

Safety and Tolerability of Repeat Doses of ACU-4429 in Healthy Subjects

The purpose of this study is to evaluate the safety and tolerability of repeated doses of a new investigational drug (ACU-4429) in healthy human subjects.

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Key information

Conditions

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males or females, between 25 and 55 years of age, inclusive
  • within BMI range 19 to 32 kg/m2 at Screening
  • in good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs;
  • clinical laboratory evaluations (including serum for Chem-20 [fasted at least 10 hours], CBC with differential and platelet counts, PT, INR, and aPTT, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
  • Males (or female partners of male subjects)and females must be sterile, or agree to use approved contraceptive measures throughout the study period and 45 days after the End of In House Study.
  • able to comprehend and willing to sign an Informed Consent Form.

Exclusion criteria

  • significant history or clinical manifestation of any significant metabolic, endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator);
  • history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
  • history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed;
  • history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant;
  • participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in;
  • Is currently using, or has recently received treatment with a medication disallowed by the Protocol.

Treatment and study plan

ACU-4429

Drug

administered orally once a day for 14 days

Matching placebo tablet

Drug

administered orally once a day for 14 days

Primary outcomes

  1. Safety as measured by adverse events, physical exam, ECG, vital signs, laboratory tests and visual tests

    Time frame: 20 days

Secondary outcomes

  1. Pharmacokinetics as measured by plasma ACU-4429 drug levels

    Time frame: 16 days

Sponsors and collaborators

Lead sponsor

Kubota Vision Inc.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase I, Double-Masked, Multiple Rising Dose Study of ACU-4429 in Healthy Male and Female Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 20, 2009
Registry last updated
Jan 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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